Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Status unconfirmed · Phase 4

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Key facts

Study ID

NCT00011895

Run by

GlaxoSmithKline

People needed

400

Starts

2001-02-01

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are at least 13 years old.
• Are HIV-positive.
• Have a viral load of at least 5,000 copies/ml.
• Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
• Provide written consent of a parent or guardian, if under 18 years of age.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have taken nonnucleoside reverse transcriptase inhibitors.
• Have taken other anti-HIV drugs for 2 weeks or more.
• Have an opportunistic (AIDS-related) infection.
• Are pregnant or breast-feeding.
• Have had hepatitis within the past 6 months.
• Are allergic to the study drugs or their ingredients.
• Have a mental, physical, or substance abuse disorder.
• Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
• Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.
• Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).
• Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.
• Require foscarnet or other drugs that are shown to be effective against HIV.
• Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
• Are taking experimental drugs.
• Are unlikely to complete the study or take the drugs.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Health for Life Clinic — Little Rock, Arkansas, United States
• Orange County Ctr for Special Immunology — Fountain Valley, California, United States
• Pacific Horizons Med Group — San Francisco, California, United States
• Beacon Clinic / Boulder Community Hosp — Boulder, Colorado, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Dupont Circle Physicians Group — Washington D.C., District of Columbia, United States
• Infectious Disease Consultants — Altamonte Springs, Florida, United States
• North Broward Hosp District / HIV Clinical Research — Fort Lauderdale, Florida, United States
• Univ of Miami / Jackson Memorial Hosp — Miami, Florida, United States
• SBMA Research — Miami Beach, Florida, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• Cook County Gen Hosp / Division of Infect Diseases — Chicago, Illinois, United States
• Northstar Med Clinic — Chicago, Illinois, United States
• University of Louisville / ID Division — Louisville, Kentucky, United States
• HIV Outpatient Clinics / LA State Univ Med Ctr — New Orleans, Louisiana, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Dr Paul Benson — Berkley, Michigan, United States
• Hennepin County Med Ctr — Minneapolis, Minnesota, United States
• Regions Hosp / HIV/AIDS Program — Saint Paul, Minnesota, United States
• CRC of Mississippi — Jackson, Mississippi, United States
• Wellness Ctr / Las Vegas — Las Vegas, Nevada, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NJCRI — Newark, New Jersey, United States
• SUNY / Health Sciences Ctr at Brooklyn — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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